BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131467·TiBase NB RP .3G NE

    GLASIONOMER FX-II

    FDA 510(k)
    FDA Class 2 ·Dental

    FLEXI-Q DV AND DVR AUTO-INJECTORS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    ESTEEM

    FDA Adverse Event
    Other ·ENVOY MEDICAL·Product code OAF·May 7, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 16, 2011

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 20, 2013

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 20, 2013

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014